Comparison of an Electronic Version of Selected COPD PRO Instruments With the Original Versions

COPD Clinical Trial

Official title:

Comparison of an Electronic Version of Selected COPD PRO Instruments With the Original Versions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01875302
• Other study ID #: NSH-001
• Status: Completed
• Phase: N/A
• First received: April 22, 2013
• Last updated: June 17, 2013
• Start date: February 2013
• Est. completion date: May 2013

Study information

• Verified date: June 2013
• Source: nSpire Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

This protocol defines the requirements to demonstrate that the PRO instruments which were designed as paper-based are equivalent to the nSpire Health ePRO (electronic patient reported outcome), following the ISPOR's ePRO Good Research Practices Task Force recommendations. All validation studies of the questionnaires were conducted using the original paper versions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• Give their signed written informed consent to participate

• Current symptoms COPD, as diagnosed by a physician

• Age 40 - 75 years

• Able to read and understand English

Exclusion Criteria:

• Unwilling to complete the 3 electronic PRO questionnaires or participate in an interview during completion of questionnaires

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• COPD

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
nSpire Health, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demonstrate that the following PRO instruments which were designed as paper-based are equivalent to the nSpire Health ePRO (electronic patient reported outcome)	The primary measures to demonstrate equivalency of electronic to paper PRO instruments are Usability and Cognitive Debriefing.; Usability data is gathered using systematic observation under controlled conditions to determine how well the device may be used by subjects.; Qualitative, Content Analysis of Cognitive Debriefing Data The cognitive debriefing data will be content analyzed for subject understanding of the instructions on the device used to deliver the PRO instrument.	60 minutes	No